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510(k) Data Aggregation

    K Number
    K961719
    Device Name
    EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
    Manufacturer
    HOWMEDICA LEIBINGER, INC.
    Date Cleared
    1997-07-17

    (441 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K990458
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples:

    • Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair Pieces
      Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Epitec™ Titanium Implant System. It does not contain the acceptance criteria or details of any study proving the device meets acceptance criteria.

    The letter states that the device has been found substantially equivalent to predicate devices, allowing it to be marketed, but does not include information about performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information based on the input document.

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